HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
Device Facts
| Record ID | K181310 |
|---|---|
| Device Name | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile |
| Applicant | Cardiocomm Solutions, Inc. |
| Product Code | DXH · Cardiovascular |
| Decision Date | Feb 22, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2920 |
| Device Class | Class 2 |
Indications for Use
The HeartCheck™ Cardi Beat ECG Monitor device with the GEMS Mobile software is an over-the-counter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server. The HeartCheck™ Cardi Beat ECG Monitor combined with GEMS Mobile software is indicated for users who are concerned about their heart rhythms and may have experienced symptoms that may suggest irregular or abnormal heart rhythms. Symptoms may include: - Skipped beats - Palpitations - Racing heart - Fainting and lightheadedness - Irregular rate - History of any related heart abnormalities The HeartCheck™ Cardi Beat ECG Monitor along with the GEMS Mobile software is not intended to substitute a hospital diagnostic ECG device. Users with an implanted pacemaker or are not recommended to use this device while the implanted device is operational. Users where their pacemaker is operational will not be able to record their ECG under normal sinus rhythm with the pacemaker on.
Device Story
HeartCheck CardiBeat is a 1-lead ambulatory ECG monitor; captures 30-second single-channel ECG signals via touch-activated metal electrodes. Device transmits data via secure Bluetooth to GEMS Mobile app on smartphone/tablet. Data stored locally or transmitted to remote server for review by qualified health professionals. Used by patients in home/non-clinical settings. Output consists of ECG waveforms displayed on mobile app after physician pre-review. Facilitates remote monitoring; assists physicians in confirming presence/absence of arrhythmias. Benefits patients by enabling capture of real-time cardiac events for clinical assessment.
Clinical Evidence
No clinical testing was conducted to support this submission. Bench testing only.
Technological Characteristics
1-lead ECG monitor; metal electrodes; 3.7V 230mAh lithium battery; Bluetooth connectivity; software-based signal processing. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-25 (ECG performance), IEC 62304 (software lifecycle), and ISO 10993 (biocompatibility).
Indications for Use
Indicated for adults 21+ concerned about heart rhythms or experiencing symptoms (skipped beats, palpitations, racing heart, fainting/lightheadedness, irregular rate, history of heart abnormalities). Contraindicated for users with operational implanted pacemakers.
Regulatory Classification
Identification
A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.
Predicate Devices
- HeartCheck™ ECG PEN (K111159)
Reference Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.
February 22, 2019
CardioComm Solutions, Inc. Jill Turcotte Quality and Regulatory Manager 259 Yorkland Road, Suite 200 North York, Ontario Canada M2J 0B5
Re: K181310
Trade/Device Name: HeartCheck Cardi Beat ECG Monitor with GEMS Mobile Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH Dated: January 21, 2019 Received: January 22, 2019
Dear Jill Turcotte:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
**Jessica E. Paulsen -S**
- for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
## 510(k) Number (if known) K181310
#### Device Name
HeartCheck™ Cardi Beat ECG Monitor (also know as HeartCheck™ Beat) with GEMS Mobile
#### Indications for Use (Describe)
The HeartCheck™ Cardi Beat ECG Monitor device with the GEMS Mobile software is an over-the-counter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server.
The HeartCheck™ Cardi Beat ECG Monitor combined with GEMS Mobile software is indicated for users who are concerned about their heart rhythms and may have experienced symptoms that may suggest irregular or abnormal heart rhythms. Symptoms may include:
- · Skipped beats
- · Palpitations
- · Racing heart
- Fainting and lightheadedness
- · Irregular rate
- · History of any related heart abnormalities
The HeartCheck™ Cardi Beat ECG Monitor along with the GEMS Mobile software is not intended to substitute a hospital diagnostic ECG device. Users with an implanted pacemaker or are not recommended to use this device while the implanted device is operational. Users where their pacemaker is operational will not be able to record their ECG under normal sinus rhythm with the pacemaker on.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> |
|----------------------------------------------|---------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☒ |
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HeartCheck™ CardiBeat ECG Monitor with GEMS Mobile
K181310 510(k) Summary
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| Document Title: | HeartCheck <sup>TM</sup> CardiBeat ECG Monitor with GEMS Mobile K181310 510(k) Summary |
|-------------------|-----------------------------------------------------------------------------------------------------------|
| Document Number: | F5S-001 |
| Document Author: | Jill V Turcotte |
| Document Version: | 1.0 |
| | <div> CardioComm <br/> Solutions, Inc. </div> |
| | <div>Page: <br/> 2 of 7 </div> |
# Table of Contents
| 1 | | K181310 Summary | |
|---|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 1.1 | Device Description | |
| | 1.2 | Indications for Use…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… | |
| | 1.3 | Testing Summary | |
| | 1.3.1 | Nonclinical Testing | |
| | 1.3.2 | Clinical Testing | |
| | 1.3.3 | Substantial Equivalent (SE) Comparison Summary | |
| | 1.3.4 | Conclusion | |
# List of Figures
No table of figures entries found.
# List of Tables
| Table 1 – Compliant Standards ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Table 2- SE Comparison Summary | |
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| Document Title: | HeartCheck™ CardiBeat ECG Monitor with GEMS Mobile K181310 510(k) Summary | | CardioComm<br>Solutions, Inc. | |
|-------------------|---------------------------------------------------------------------------|------------------|-------------------------------|--|
| Document Number: | F5S-001 | Document Author: | | |
| Document Version: | 1.0 | | | |
#### K181310 Summary ।
| Submitter: | CardioComm Solutions, Inc. | | |
|-------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--|
| Address: | 200-259 Yorkland Road<br>North York, Ontario M2J 0B5 | | |
| Phone: | 416.977.9425 | | |
| Contact Person(s): | Etienne Grima<br>CEO<br>egrima@cardiocommsolutions.com | Jill Turcotte,<br>QA, RA & Infrastructure Manager<br>jturcotte@cardiocommsolutions.com | |
| Date of Summary: | 2018-05-01 | | |
| Trade/Proprietary Name: | HeartCheck™ CardiBeat ECG Monitor or HeartCheck™ Cardi or HeartCheck™ Beat and<br>GEMS™ Mobile | | |
| Common/Usual Name: | HeartCheck™ CardiBeat ECG Monitor or HeartCheck™ Cardi or HeartCheck™ Beat | | |
| Classification Name | Class II | | |
| Product Code: | DXH | | |
| Regulations: | 870.2920 | | |
| SE Predicate Device(s): | HeartCheck™ ECG PEN K111159 | | |
| SE Reference Device(s): | ECG Check K122184 | | |
# 1.1 Device Description
The HeartCheck™ CardiBeat ECG Monitor device model HC-WE-01 is an ambulatory and telemedicine based solution that is intended to enable uses to record, store, transfer, and display single channel ECG waveforms. The HeartCheck™ CardiBeat ECG Monitor combined with GEMS™ Mobile enables the user to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional, such as a physician.
The 1 lead ECG Event Monitor is specifically designed to operate with GEMS™ Mobile software, a smartphone software configured to run on mobile devices such as smartphones and tablets. The device will record a pre-selected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event.
The HeartCheck™ CardiBeat ECG Monitor is activated through touch by the user whenever a recording is needed. The recorded data serves as a reliable heart rhythm record that may later be shown to physicians or other health care professionals for confirmation of the presence or absence of an arrhythmia. When a user feels that a cardiac event is occurring, the utilization of the HeartCheck™
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| Document Title: | HeartCheck™ CardiBeat ECG Monitor with GEMS Mobile K181310 510(k) Summary |
|-------------------|---------------------------------------------------------------------------|
| Document Number: | F5S-001 |
| Document Author: | Jill V Turcotte |
| Document Version: | |
Image /page/6/Picture/1 description: The image shows a logo with a heart in the center. The heart is red and black. There are two curved shapes on either side of the heart. The shape on the left is black, and the shape on the right is red.
CardiBeat ECG Monitor with GEMS™ Mobile has the feature of recording this real time data that would otherwise not be possible to capture.
While performing the recording, data is continuously sent to the smartphone or tablet by secure Bluetooth connection technology. Following an initial physician review, the ECG can be displayed for quality and observation purposes on the GEMS™ Mobile application. Users will not be able to view the waveform without a physician's pre-review from the SMART Monitoring system. This system used the HeartCheck™ ECG PEN and GEMS™ Home system (K11159) with an ECG reading service as a predicate device. The recorded data can be stored locally on the mobile device and/or not transmitted to CardioComm Solutions, Inc.'s SMART Monitoring ECG reading service (powered by GlobalCardio™ K111320) for analysis and assessment by qualified professionals.
# 1.2 Indications for Use
1.0
The HeartCheck™ CardiBeat ECG Monitor device with the GEMS™ Mobile software is an over-thecounter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server.
The HeartCheck™ CardiBeat ECG Monitor combined with GEMS™ Mobile software is indicated for users who are concerned about their heart rhythms and may have experienced symptoms that may suggest irregular or abnormal heart rhythms. Symptoms may include:
- . Skipped beats
- . Palpitations
- Racing heart
- Fainting and lightheadedness
- . Irregular rate
- History of any related heart abnormalities
The HeartCheck™ CardiBeat ECG Monitor along with the GEMS™ Mobile software is not intended to substitute a hospital diagnostic ECG device. Users with an implanted pacemaker or are not recommended to use this device while the implanted device is operational. Users where their pacemaker is operational will not be able to record their ECG under normal sinus rhythm with the pacemaker on.
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| Document Title: | HeartCheck™ CardiBeat ECG Monitor with GEMS Mobile K181310 510(k) Summary |
|-------------------|---------------------------------------------------------------------------|
| Document Number: | F5S-001 |
| Document Author: | Jill V Turcotte |
| Document Version: | |
# 1.3 Testing Summary
1.0
# 1.3.1 Nonclinical Testing
Performance evaluation of the features described in the HeartCheck™ CardiBeat ECG Monitor user manual has been successfully completed utilizing hardware and software tests and validations. Hardware qualification is performed using the following industry standards:
| Standard Number | Standard Title |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:2005 +<br>A1:2012 | Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential Performance |
| IEC 60601-1-2:2007 | Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests |
| IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| IEC 62304:2006 | Medical Devices - Software Development Life Cycle |
| ISO 10933-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process in content |
| ISO 10933-5:2009 | Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization |
**Table 1 – Compliant Standards**
# 1.3.2 Clinical Testing
No clinical testing was conducted to support this submission.
#### 1.3.3 Substantial Equivalent (SE) Comparison Summary
| Item | Proposed Device (HeartCheck™ CardiBeat) K181310 | Primary Predicate Device K111159 | Reference Device (ECG Check) K122184 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DPS/DXH | DPS | DXH |
| Regulation<br>Number | 870.2340/870.2920 | 870.2340 | 870.2920 |
| Indications<br>for Use | The HeartCheck™ CardiBeat ECG Monitor<br>device with the GEMS™ Mobile software<br>is an over-the-counter device intended<br>to record, store and transfer single<br>channel Heart Rhythm signals and<br>display Heart Rhythm waveforms. This 1-<br>lead cardiac monitor allows remote users<br>to display and transmit their ECG data to<br>medical professionals via a<br>communication device to a remote<br>server.<br>The HeartCheck™ CardiBeat ECG Monitor<br>combined with GEMS™ Mobile software<br>is indicated for users who are concerned<br>about their heart rhythms and may have<br>experienced symptoms that may suggest | The HeartCheck™ Pen Handheld with<br>GEMS™ Home software is an over-the-<br>counter device intended to record, store,<br>transfer single channel Heart Rhythm signals<br>and, for users under a physician's care,<br>display Heart Rhythm waveforms. The<br>HeartCheck™ Pen Handheld device along<br>with GEMS™ Home software is not intended<br>to substitute a hospital diagnostic ECG<br>device. The device is not intended for<br>simultaneously recording and transmitting a<br>user's Heart Rhythm.<br>Users with an implanted pacemaker or a<br>defibrillator are not recommended to use<br>this device. | The ECG Check is intended for self-testing by<br>patients at home. This 1-lead cardiac monitor<br>allows remote patients to display and<br>transmit their ECG data to medical<br>professionals via a communication device to a<br>remote server.<br>Specifically, the ECG Check is indicated for<br>patients who are concerned about their heart<br>rhythm and experienced the following<br>symptoms that are suggestive of abnormal<br>heart rhythms:<br>● Skipped Beats<br>● Pounding Heart (Palpitations)<br>● Heart Racing or Irregular Pulse |
| Item | Proposed Device (HeartCheck™ CardiBeat) K181310 | Primary Predicate Device K111159 | Reference Device (ECG Check) K122184 |
| | irregular or abnormal heart rhythms.<br>Symptoms may include:<br>Skipped beats Palpitations Racing heart Fainting and lightheadedness Irregular rate History of any related heart abnormalities The HeartCheck™ CardiBeat ECG Monitor<br>along with the GEMS™ Mobile software<br>is not intended to substitute a hospital<br>diagnostic ECG device. Users with an<br>implanted pacemaker or are not<br>recommended to use this device while<br>the implanted device is operational.<br>Users where their pacemaker is<br>operational will not be able to record<br>their ECG under normal sinus rhythm<br>with the pacemaker on. | GEMS™ Home is a simple software user<br>interface for managing Heart Rhythm<br>recordings and associated data.<br>Record the Heart Rhythm waveform for an<br>adult. If under the guidance of a qualified<br>Health Care Professional, the software and<br>device can be unlocked to display the Heart<br>Rhythm. | Lightheadedness or Faintness History of Arrhythmias |
| Population | Adult (=> 21 years of age) | Not indicated | Not indicated |
| Lead | 1 lead | 1 lead | 1 lead |
| Recording<br>Mode | Automatic, 30 seconds | Automatic, 30 seconds | Automatic, 30 seconds |
| Measurement<br>Parameters | Heart rate<br>ECG waveform | Heart rate<br>ECG waveform | Heart rate<br>ECG waveform |
| Display | None | Yes - OLED | None |
| Power Supply | 3.7 V 230 mAh lithium battery<br>5V 115 mA (for charging only) | 3 V (2 AAA alkaline batteries) | 3.7 V 230 mAh lithium battery<br>5V 115 mA (for charging only) |
| Electrical<br>Safety | The proposed device was tested to<br>demonstrated to comply with IEC 60601-<br>1 | IEC 60601-1 | IEC 60601-1 |
| EMC | The proposed device was tested to<br>demonstrated to comply with IEC 60601-<br>1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| Patient<br>Contact<br>Material | Metal electrode | Metal electrode | Metal electrode |
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#### Document Title:
1.0
HeartCheck™ CardiBeat ECG Monitor with GEMS Mobile K181310 510(k) Summary
Document Number: F5S-001 Document Version:
Document Author: Jill V Turcotte
Image /page/8/Picture/4 description: The image shows a logo with a heart shape in the center. The heart is formed by two curved lines, one red and one black. On either side of the heart are curved lines that are black on the left and red on the right. The overall design is abstract and symmetrical.
Page: 6 of 7
#### Table 2- SE Comparison Summary
## 1.3.4 Conclusion
The applicant device, HeartCheck™ CardiBeat ECG Monitor, indications for use and indications for use are the same as the predicate device HeartCheck™ Pen Handheld ECG Monitor and the reference
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| Document Title: | HeartCheck™ CardiBeat ECG Monitor with GEMS Mobile K181310 510(k) Summary |
|------------------|---------------------------------------------------------------------------|
| Document Number: | F5S-001 |
| Document Author: | Jill V Turcotte |
Document Version:
1.0
Image /page/9/Picture/1 description: The image shows a logo with a heart shape in the center. The heart is red and black. There are two curved shapes on either side of the heart. The shape on the left is black, and the shape on the right is red.
device, ECG Check by Cardiac Designs. The new applicant, predicate and reference devices have identical patient populations and places of use. In addition, the parameters that are measured by the new HeartCheck™ CardiBeat ECG Monitor are equal to primary predicate HeartCheck PEN Handheld device with GEMS™ Home and to the reference device, ECG Check by Cardiac Designs.
